The present invention relates to a device for medical imaging and diagnosis and in particular for imaging methods suitable for examining the tissue of the uterus, cervix, and pelvic floor.
The uterus is a vase-like muscular organ the shape of an upside down pear about two and one-half inches long in non-pregnant women. The narrow neck of the uterus is called the cervix. An examination of the uterus is typically performed by touch (palpation) during which the physician explores the contours of the uterus and cervix using his or her fingers while pressing down on the abdomen. In this way, in some cases, the physician may detect tumors or cysts.
X-ray imaging methods, including computed tomography (CT), do not work well with the soft tissue of the uterus. Ultra-sound imaging may be employed, however, uterine fibroids and adenomyosis foci appear similar on conventional ultrasound scans making differentiation very difficult for the sonologist. Currently, magnetic resonance imaging (MRI) is the only imaging modality capable of characterizing these two conditions but MRI imaging is expensive, limiting its use as a screening tool.
Some problems with the uterus are manifest by postmenopausal bleeding which may be caused by a benign etiology (endometrial atrophy, hyperplasia, polyps, or leiomyomas). However, approximately 10-30% of women with menopausal bleeding will be found to have endometrial cancer. Distinguishing between these etiologies is difficult with current imaging technology.
Pre-term delivery is a complex problem that may result from incompetence of the cervix of the uterus. Although cervical incompetence is believed to be the principal causative factor in approximately 25% of miscarriages, it is difficult to determine which pregnancies might benefit from intervention and what the appropriate intervention might be. For example, the attending physician may recommend cerclage or simply prolonged bed rest.
A history of pre-term delivery may be used to estimate the chance of pre-term delivery or, alternatively, such a risk may be estimated from the length of the cervix usually measured with a trans-vaginal ultrasound image. However, cervical length has not proven to be a wholly reliable indicator of this condition.
Pelvic floor disorders, such as incontinence and prolapse, result from failure of the fibromuscular connective tissue sheath that forms the supporting structure for the organs of the deep pelvis. The identification of defects in this support structure is important for surgical planning and repair. At present, MRI imaging provides the only means of assessing these structures, but such imaging is expensive and available only in the larger centers.